The following data is part of a premarket notification filed by Winfield Laboratories, Inc. with the FDA for Absorbent Pad -- Modification.
| Device ID | K923602 |
| 510k Number | K923602 |
| Device Name: | ABSORBENT PAD -- MODIFICATION |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | WINFIELD LABORATORIES, INC. 1303 COLUMBIA SUITE 207 Richardson, TX 75081 |
| Contact | Gary W Cummings |
| Correspondent | Gary W Cummings WINFIELD LABORATORIES, INC. 1303 COLUMBIA SUITE 207 Richardson, TX 75081 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-15 |
| Decision Date | 1992-12-07 |